GB/T 19335-2022 PDF English
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| GB/T 19335-2022 | English | 230 |
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Blood flow products for single use - General specification
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| GB 19335-2003 | English | 125 |
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Blood flow products for single use -- General specification
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GB/T 19335-2022: Blood flow products for single use - General specification---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT19335-2022
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
CCS C 31
Replacing GB 19335-2003
Blood flow products for single use - General specification
Issued on. APRIL 15, 2022
Implemented on. MAY 01, 2023
Issued by. State Administration for Market Regulation;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 General requirements... 6
5 Materials... 6
6 Design... 6
7 Requirements... 8
8 Packaging, marks... 11
Annex A (informative) Design and evaluation requirements... 12
Annex B (normative) Test methods for pressure monitoring joints/sensor protectors 14
Annex C (informative) Example for preparation of chemical performance test solution
... 17
Annex D (informative) Standard implementation guide... 18
Bibliography... 19
1 Scope
This Standard specifies the general technical conditions for blood flow products for
single use.
This Standard applies to the blood flow products for single use and the auxiliary
pipelines connected to them, including the products composed of liquid flow and
pressure monitoring pipeline (hereinafter referred to as "blood flow").
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB 8369 (all parts), Transfusion sets for single use
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for
medical use - Part 1.Chemical analysis methods
GB/T 14233.2, Test methods for infusion, transfusion, injection equipment for
medical use - Part 2.Biological test methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1.Evaluation and
testing within a risk management process
GB/T 19633.1, Packaging for terminally sterilized medical devices - Part 1.
Requirements for materials, sterile barrier systems and packaging systems
YY/T 0316, Medical devices - Application of risk management to medical devices
YY 0581.1, Infusion access adapters - Part 1.Needle access adapters (Heparin
plugs)
3 Terms and definitions
There are no terms and definitions that need to be defined in this document.
4 General requirements
It shall use the established risk assessment procedures to design the blood flow products.
When transporting, storing, installing, using and maintaining blood flow products in
accordance with the manufacturer's instructions, under normal and single failure
conditions, use risk management procedures in accordance with YY/T 0316.Blood
flow products shall not present risks that are not reduced to acceptable levels and are
associated with their intended use.
5 Materials
The pipelines directly or indirectly in contact with blood shall be made of materials that
meet relevant standards. Leachables from the blood flow due to chemical or physical
effects of anticoagulants and/or maintenance fluids, blood and blood components shall
be within specified limits.
6 Design
6.1 Protective cover
Each inlet and outlet of the blood flow (except for the inlet and outlet of the pressure
monitoring connector/sensor protector) shall have a protective cover. The protective
cover shall be secure and easy to remove.
6.2 Injectors
6.2.1 Needleless injectors
The needle-free injectors on the blood flow shall meet the relevant requirements of YY
0581.2.
6.3 Connectors
6.3.1 Luer connectors
Luer connectors shall comply with the requirements of ISO 80369-7.
6.3.2 Reservoir connectors
Connectors connected to citrate anticoagulants shall meet the requirements of ISO
18250-8.2018.
6.4 Blood and blood component filters
If there is a blood and blood component filter in the transfusion direction of the blood
flow product, it shall be designed to allow filtering only in the direction of the
transfusion.
6.5 Switches
The flow regulator in the blood flow shall comply with the relevant requirements of GB
8369 (all parts).
6.6 Pressure monitoring joint/sensor protector
6.6.1 Appearance
The machine end of the pressure monitoring joint/sensor protector shall be transparent.
Blood contamination can be checked visually during use.
6.6.3 Pressure transfer performance
The pressure monitoring joint/sensor protector shall have adequate pressure
transmission performance.
6.6.4 Blood blocking
The filter material in the pressure monitoring joint/sensor protector can effectively
block the liquid. When tested according to B.3, under the hydraulic pressure of 40kPa
for 40s, there shall be no evidence of liquid penetration.
7 Requirements
7.1 General
Blood flows are designed to maintain high quality blood or blood components. The
blood flow is sterile and pyrogen-free under the expected conditions of use.
7.2 Physical properties
7.2.1 Appearance
The hose on the blood flow shall be plasticized evenly without kinks. Its transparency
shall allow detection of air bubbles in the bloodstream with normal or corrected vision.
7.2.3 Connection firmness
Each connection of the blood flow (excluding the protective sleeve) shall be able to
withstand a static axial tension of 15N. It shall last 15s without breaking and falling off.
7.2.4 Particulate pollution
Blood flows shall be produced with minimal particulate contamination. Liquid passage
surfaces shall be smooth and clean. When tested according to the method specified in
YY/T 1556, the pollution index shall not exceed 90.
7.2.5 Color code
When the blood flow is divided into arterial blood flow and venous blood flow, there
shall be a clear color mark within 100mm of the end of the pipeline. The arterial blood
flow shall be red. The venous blood flow shall be blue.
7.3 Chemical properties
7.3.1 Guide for test solution preparation
The preparation conditions of the chemical performance test solution shall represent the
most severe conditions for the clinical use of the product. Design the reasonable and
feasible extraction ratio, extraction temperature and extraction time. Prepare the blank
control solution in the same way.
7.3.2 Color
When observing the test solution with normal vision or corrected vision, the test
solution shall be colorless and transparent.
7.3.3 Reducing substances
When testing according to 5.2.2 of GB/T 14233.1-2008, the difference between the
volume of potassium permanganate solution [c(KMnO4)=0.002mol/L] consumed by
20mL of test solution and blank solution shall not exceed 2.0mL.
7.3.5 pH
When testing according to 5.4.1 in GB/T 14233.1-2008, the test solution is compared
with the blank solution of the same batch. The difference in pH value shall not exceed
1.5.
7.5 Biological properties
7.5.1 General requirements
Blood flow products shall be biologically evaluated according to GB/T 16886.1.
7.5.2 Sterile
Blood flow products shall be supplied sterile and shall meet the requirements of YY/T
0615.1.
7.5.3 Bacterial endotoxin
Blood flow products shall control bacterial endotoxin content in corresponding product
standards. Carry out the test according to the test method given in GB/T 14233.2.It
shall not exceed 20EU/set.
8 Packaging, marks
The manufacturer of the blood flow shall provide evidence that its single package
complies with GB/T 19633.1.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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